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The FDA has approved KalydecoTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. Kalydeco is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Approximatel 1,200 people in the United States, or 4% of those with CF, are believed to have this mutation.

Kalydeco was granted approval in approximately 3 months, making it one of the fastest FDA approvals ever and marking the second approval of a new medicine from Vertex in less than a year.

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